Global Regulatory Affairs Leader

7 days ago

nellore, India beBeeRegulatory Full time

Regulatory Affairs SpecialistWe are seeking an experienced Regulatory Affairs Specialist to lead global regulatory submissions and compliance efforts. This role will be responsible for authoring and compiling regulatory dossiers for various health authorities, conducting dossier gap analysis, converting and preparing dossiers in multiple formats, and managing end-to-end preparation and submission of lifecycle submissions.Main Responsibilities:Develop and submit regulatory dossiers to global health authorities.Analyze dossier gaps to identify document and data deficiencies.Prepare dossiers in multiple formats including eCTD, ACTD, and CTD.Oversee the preparation and submission of ANDA, NDA, BLA, MAA, and other lifecycle submissions.Collaborate with cross-functional teams to respond to health authority queries.Maintain a strong understanding of CMC, clinical, non-clinical, and administrative documentation to ensure successful global submissions.Project Management:Manage simultaneous regulatory submissions for multiple products across multiple countries.Utilize project management tools to track project milestones, timelines, and deliverables.Efficiently allocate time and resources to meet submission deadlines.Foster seamless communication between central regulatory, regional teams, and stakeholders.Requirements:8–10 years of core experience in Regulatory Affairs.Strong knowledge of global dossier formats, submission pathways, and lifecycle management.Excellent cross-functional collaboration and coordination skills.Proven ability to manage complex multi-country regulatory portfolios.

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